Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270361
Status:
COMPLETED
Last Update Posted:
2011-07-26
First Post:
2005-12-22
Brief Title:
FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR Nesiritide Administered to Patients With Worsening Congestive Decompensated Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
Official Title:
Management of Patients With CHF After Hospitalization-Follow up Serial Infusions of NATRECOR Nesiritide - FUSION I A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of two doses of nesiritide a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure when administered serially as a treatment to outpatients with worsening congestive heart failure decompensated CHF who are receiving their usual cardiac medications and are at high risk for hospitalization
Detailed Description:
Efforts to contain rising costs for hospital acute care have resulted in shorter hospital stays for patients with acutely decompensated heart failure These shorter stays may not allow for adequate diuresis titration of oral medications or for patients to receive the full benefit of intravenously IV administered medications In addition to shorter stays when hospitalized physicians are exploring ways to treat patients in the outpatient setting to avoid hospitalization Although there is increasing interest among clinicians in the use of outpatient IV therapy for the treatment of advanced heart failure there is no consensus among clinicians regarding patient selection dosing or treatment duration The use of IV inotropic agents drugs that influence and or affect muscle contractility such as milrinone or dobutamine in this setting is controversial and may lead to increased mortality Indeed the ACCAHA American College of Cardiology and American Hospital Association guidelines warn that long-term intermittent use of IV inotropes for treatment of left ventricular dysfunction is of unproved value and not recommended Yet despite these guidelines clinicians use inotropes in the outpatient setting because there is no currently approved alternative therapy Thus there is an unmet need for effective outpatient treatment of advanced chronic heart failure to improve quality of life andor reduce the number of hospital admissions for heart failure
The data from previous studies suggest that doses of NATRECOR hBNP may be a potent agent for the treatment of acute congestive heart failure CHF with a unique combination of desirable effects on the flow of blood throughout the body the hormones secreted by the nervous system and support of copious salt outputs by the renal system not provided by currently available therapies This study is a multicenter open-label pilot study in which subjects who have received treatment for acutely decompensated CHF during a hospitalization at least twice within the previous 12 months are randomized 111 to one of three treatment groups One treatment group will receive their usual long term cardiac medications either with or without serial infusions of inotropes various drugs that affect the strength of contractions of the heart muscle and without nesiritide therapy The 0005 mcgkgmin nesiritide treatment group receives a 05 mcgkg bolus of nesiritide followed by a 00025 mcgkgmin infusion in addition to their usual long term cardiac medications excluding IV inotropes The 0010 mcgkgmin nesiritide treatment group receives a 1 mcgkg bolus of nesiritide followed by a 0005 mcgkg infusion in addition to their usual long term cardiac medications excluding IV inotropes Because patients treated in an outpatient setting may be less decompensated than patients with acutely decompensated heart failure this study was designed to evaluate the 0010 mcgkgmin dose of nesiritide the currently approved dose for acutely decompensated patients as well as a lower dose 0005 mcgkgmin
The hypothesis is that as an adjunct therapy to oral medications serial IV infusions of nesiritide may produce more rapid and sustained compensation of heart failure in patients with frequent episodes of decompensated heart failure The 0005 mcgkgmin group receives a 05 mcgkg bolus followed by a 00025 mcgkgmin infusion the 0010 mcgkgmin group receives a 1 mcgkg bolus followed by a 0005 mcgkg infusion Intravenous bolus over 60 seconds and a fixed rate infusion of 4 - 6 hours at least once per week for 12 weeks
The data from previous studies suggest that doses of NATRECOR hBNP may be a potent agent for the treatment of acute congestive heart failure CHF with a unique combination of desirable effects on the flow of blood throughout the body the hormones secreted by the nervous system and support of copious salt outputs by the renal system not provided by currently available therapies This study is a multicenter open-label pilot study in which subjects who have received treatment for acutely decompensated CHF during a hospitalization at least twice within the previous 12 months are randomized 111 to one of three treatment groups One treatment group will receive their usual long term cardiac medications either with or without serial infusions of inotropes various drugs that affect the strength of contractions of the heart muscle and without nesiritide therapy The 0005 mcgkgmin nesiritide treatment group receives a 05 mcgkg bolus of nesiritide followed by a 00025 mcgkgmin infusion in addition to their usual long term cardiac medications excluding IV inotropes The 0010 mcgkgmin nesiritide treatment group receives a 1 mcgkg bolus of nesiritide followed by a 0005 mcgkg infusion in addition to their usual long term cardiac medications excluding IV inotropes Because patients treated in an outpatient setting may be less decompensated than patients with acutely decompensated heart failure this study was designed to evaluate the 0010 mcgkgmin dose of nesiritide the currently approved dose for acutely decompensated patients as well as a lower dose 0005 mcgkgmin
The hypothesis is that as an adjunct therapy to oral medications serial IV infusions of nesiritide may produce more rapid and sustained compensation of heart failure in patients with frequent episodes of decompensated heart failure The 0005 mcgkgmin group receives a 05 mcgkg bolus followed by a 00025 mcgkgmin infusion the 0010 mcgkgmin group receives a 1 mcgkg bolus followed by a 0005 mcgkg infusion Intravenous bolus over 60 seconds and a fixed rate infusion of 4 - 6 hours at least once per week for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NATRECORHFA2001 | None | None | None |